[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.21]

[Page 61-62]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 607_ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF 
 
     Subpart B_Procedures for Domestic Blood Product Establishments
 
Sec. 607.21  Times for establishment registration and blood product listing.

    The owner or operator of an establishment entering into an operation 
defined in Sec. 607.3(d) shall register such establishment within 5 
days after the beginning of such operation and submit a list of every 
blood product in commercial distribution at the time. If the owner or 
operator of the establishment has not previously entered into such 
operation (defined in Sec. 607.3(d) of this chapter) for which a 
license is required,

[[Page 62]]

registration shall follow within 5 days after the submission of a 
biologics license application in order to manufacture blood products. 
Owners or operators of all establishments so engaged shall register 
annually between November 15 and December 31 and shall update their 
blood product listing information every June and December.

[40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56453, Oct. 20, 1999]